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NCT Number: NCT06329622

Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.

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Key information

Conditions

Chronic Kidney Disease Atrophy Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sarcopenia Signs and Symptoms Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huashan hospital, Fudan university

Shanghai, 200040, China

Location status: Recruiting

Location contact

Mengjing Wang, PhD, MD

CONTACT

[email protected]

021-52889393

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria for CKD stage 3-4 (15 ≤eGFR<60 ml/(min*1.73m2)) in the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guideline.
  • Sarcopenia should be diagnosed According to the 2019 Asian Working Group for Sarcopenia (AWGS) diagnostic criteria for sarcopenia: ① Muscle strength: grip strength (< 28 kg for males, < 18 kg for females); ② Physical function: is assessed by walking speed over 6 m (< 1.0 m/s) or five-repetition sit-to-stand test (5STS) (≥ 12 s) or recommended short physical performance battery (SPPB) (≤ 9); ③ Artificial skeletal muscle (ASM) of extremities: Bioelectrical impedance analyzer (BIA) (< 7.0 kg/m2 for males and < 5.7 kg/m2 for females). On the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met.
  • Patient can walk normally.
  • Provide the written informed consent.

Exclusion criteria

  • Patients with diabetes.
  • Obese/overweight patients (body mass index>25 kg/m2)
  • Had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis).
  • Patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months.
  • Patients with acute infection (C-reactive protein>10 mg/L) or acute exacerbation of chronic diseases that is not under control within 3 months.
  • Patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure.
  • Patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction.
  • Patients with hypercalcemia and amino acid metabolism disorder.
  • Those who are allergic to the active ingredients or other excipients of the Ketosteril.
  • Patients with poor compliance, unable to follow the study requirements for diet control.
  • Participated in other interventional clinical trials within 30 days before this study.

Treatment and study plan

low-protein diet + Ketosteril

Combination Product

low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day.

low-protein diet

Dietary Supplement

low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.

Primary outcomes

  1. skeletal muscle mass index (SMI)

    Time frame: six months after the intervention

    SMI=skeletal muscle weight/(height×height)，the muscle weight with the unit of kg and square of height with the unit of m2 will be combined to report SMI in kg/m^2

Secondary outcomes

  1. changes in eGFR(ml/min/1.73m2)

    Time frame: six months after the intervention

    From baseline to the 6th month, changes in eGFR(ml/min/1.73m2)

  2. serum albumin(g/l)

    Time frame: six months after the intervention

    From baseline to the 6th month, changes in serum albumin(g/l)

  3. grip strength(kg)

    Time frame: six months after the intervention

    From baseline to the 6th month,changes in grip strength(kg)

  4. BMI(kg/m2)

    Time frame: six months after the intervention

    From baseline to the 6th month,changes in BMI(kg/m2)

  5. 6m walking speed(s)

    Time frame: six months after the intervention

    From baseline to the 6th month,changes in 6m walking speed(s)

Study contacts

Contact information is provided by the study sponsor or research team.

Mengjing Wang, PhD, MD

CONTACT

[email protected]

02152889393

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Ketosteril Sarcopenia Chronic Kidney Disease

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 26, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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